Phase II Study on Axitinib in Advanced Solitary Fibrous Tumor

Inclusion Criteria

• •Pat centrally confirmed diagnosis of solitary fibrous tumor
• •Expression of PDGFRB and/or VEGFR2 by immunohistochemistry on formalin fixed-paraffin embedded (FFPE) material as minimal requirement. Activation of PDGFRB and/or VEGFR2 by real time C reactive protein of PDGFB and VEGFA on FFPE material (if in sufficient quantity) or by biochemistry on frozen material (if available)
• •Locally advanced disease (i.e. surgical resection of local disease unfeasible radically, or unaccepted by the patient, or amenable to become less demolitive, or feasible, or easier, after cytoreduction) and/or metastatic disease
• •Measurable disease
• •Centrally confirmed evidence of progression by RECIST during the 6 months before study entry
• •1st-line vs 3-rd-line
• •Eastern Cooperative Oncology Group (ECOG) Performance Status = 0, 1, 2
• •Adequate bone marrow function, defined as the following: absolute neutrophil count (ANC) \>1.5 x 109/L, platelets \>100 x 109/L, Hb \>9 g/dL. Blood transfusions are allowed to reach the baseline requested Hb level
• •Adequate organ function, defined as the following: total bilirubin within normal institutional limits (but in case of Gilbert's syndrome), aspartate aminotransferase (AST) and Serum Glutamic Pyruvic Transaminase (ALT) \<2.5 x upper normal limit (UNL), creatinine \<1.5 x upper normal limit (UNL), within normal institutional limits or creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
• •Cardiac ejection fraction ≥50% as measured by echocardiogram
• •Age \> 18 yrs
• •Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study and for up to 3 months following discontinuation of study drug
• •No history of arterial and/or venous thromboembolic event within the previous 12 months
• •Written, voluntary informed consent